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Heart Disease Newsletter
July 14, 2008


In This Issue
• Assisted Breathing Eases Lung Symptoms for Heart Patients
• Ankle-Arm Blood Pressure Test Predicts Heart Disease Risk
• Sudden Hearing Loss May Portend Stroke
• Danger From Heart Surgery Drug Confirmed
 

Assisted Breathing Eases Lung Symptoms for Heart Patients


WEDNESDAY, July 9 (HealthDay News) -- Assisted breathing improves the symptoms of patients whose lungs fill with water because of a weak heartbeat, but it doesn't reduce death rates, a new British study shows.

The study found no significant difference between two forms of assisted breathing -- continuous positive airway pressure (CPAP) and noninvasive intermittent positive-pressure ventilation (NIPPV). Both deliver more air to the lungs through face masks -- CPAP continuously, NIVVP in an on-and-off fashion.

The study, led by physicians at the University of Edinburgh, included 1,069 people, average age 77, hospitalized with what is formally called cardiogenic pulmonary edema -- accumulation of fluid in the lungs due to a weak heartbeat.

Standard treatment in such cases concentrates on improving heart function, said Dr. Arnold Baas, a cardiovascular disease specialist at the University of California, Los Angeles. Many patients also get oxygen through nose tubes.

"Lots of small studies suggested that a noninvasive breathing support mechanism might be of benefit," Baas said. "This is the largest randomized trial showing whether pushing air into the lungs might help."

In the British study, reported in the July 10 issue of the New England Journal of Medicine, one-third of the participants got conventional oxygen therapy, one-third were given CPAP, and one-third received NIVVP.

"The long and short of it is that they showed these interventions improved symptoms and blood chemistry but didn't help patients live longer," Baas said.

People getting either of the assisted breathing treatments reported less shortness of breath and had better heartbeats and fewer blood abnormalities than those getting conventional oxygen therapy. But deaths during the seven days of treatment were about the same for those getting conventional oxygen therapy (9.8 percent of patients) and those with assisted breathing (9.5 percent).

The percentage of those getting assisted breathing who died or required more serious intervention in those seven days was about the same for CPAP (11.7 percent) and NIVVP (11.1 percent).

The improvement in symptoms means that assisted breathing is worth using for pulmonary edema, Baas said. "It did make people feel more comfortable," he noted.

Both methods are readily available in hospitals, Baas said, but CPAP probably is preferable because it is in wider use by people with sleep apnea, who can do it at home, he explained.

More information

Pulmonary edema and its treatment are described by the U.S. Library of Medicine.


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Ankle-Arm Blood Pressure Test Predicts Heart Disease Risk


TUESDAY, July 8 (HealthDay News) -- A seldom-used test that measures blood pressure in the ankle and the arm can help improve assessment of the risk of heart disease, stroke and other cardiovascular problems, an international research group reports.

It has a distinct advantage in that it is extremely easy to perform and doesn't require expensive, sophisticated equipment, Gerry Fowkes, a professor of epidemiology at the University of Edinburgh, Scotland, said of the ankle brachial index (ABI). The device is the subject of a report in the July 9 issue of the Journal of the American Medical Association. The index is the ratio between the blood pressure measurements in the ankle and the arm.

The ABI should be used to supplement rather than replace standard measures of cardiovascular risk such as cholesterol, blood pressure, obesity and physical activity, Fowkes said.

"It has been shown that using these common risk factors, prediction is not as good as it might be," he said. "That is why we and others have been looking for other factors to improve prediction."

The meta-analysis used data from 16 studies around the world, including 24,955 men and 23,339 women who were followed after an initial ABI measurement. Over the next 10 years, 4.4 percent of men with a normal ABI died, compared to 18.7 percent of men with an abnormally low ABI. Death rates for women were 12.6 percent for those with a low ABI, 4.1 percent for those with a normal ABI.

A lower ABI was associated with approximately a doubled risk of death from any cause, cardiovascular death, and a major coronary event over the 10 years, the report said. Including the ABI in current risk factor assessments would mean reclassification of cardiovascular risk and change of the measures taken to prevent cardiovascular events for 19 percent of men and 36 percent of women, the researchers estimated.

Studies about the use of the ABI are continuing, Fowkes said. "The next step is to look at the prediction made by combining the ABI and other risk factors," he said. "Any individual who is having a cardiovascular risk assessment would benefit from having this test, but when we have done further work in looking at the detailed accuracy of the prediction, proper use of the test will become more obvious."

ABI testing right now isn't for everyone, said Dr. Aaron B. Folsom, a professor of epidemiology at the University of Minnesota, and a member of the research team.

It is being promoted as a way of measuring the risk of peripheral arterial disease (PAD), blockage of blood vessels in the legs, and so it is best used for older people, who are at greater risk of PAD, Folsom said. Wider use can be proposed, because "the more information you have, the better you do in classifying cardiovascular risk," Folsom said.

A low ABI reading would mean greater emphasis for that individual on the classic risk factors -- blood cholesterol, blood pressure, diabetes, obesity and the others, Folsom added. "We do have interventions that we know work, such as glucose-lowering and physical activity," he said.

More information

Learn how the ABI is determined and what it means from the Vascular Disease Foundation  External Links Disclaimer Logo.


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Sudden Hearing Loss May Portend Stroke


THURSDAY, June 26 (HealthDay News) -- Sudden hearing loss may foreshadow a stroke by as much as two years,say Taiwanese researchers.

The researchers analyzed five years of follow-up data on 1,423 patients hospitalized for an acute episode of sudden hearing loss and found they were more than 1.5 times more likely to suffer a stroke than a control group of 5,692 patients hospitalized for an appendectomy.

The findings, published in the current issue of Stroke, haven't been duplicated in other research and should be interpreted with caution.

"To the best of our knowledge, no study has investigated the incidence or risk of cerebrovascular diseases developing following the onset of sudden sensorineural hearing loss," lead investigator Herng-Ching Lin, a professor at Taipei Medical University School of Health Care Administration, said in a prepared statement.

"But because this is the first time any association has been suggested, and because there were many limitations in the data, the results need to be interpreted cautiously until additional independent studies are performed," Lin said.

One limitation was the lack of a clear definition for sudden sensorineural hearing loss in the database reviewed by the researchers.

"Secondly, the database did not contain information regarding severity of hearing loss, extent of hearing recovery, tobacco use, body-mass index and the medical history of cardiovascular disease and atrial fibrillation -- all of which can contribute to stroke risk," Lin said.

Even so, the researchers recommended that all hearing loss patients have a comprehensive neurological exam and blood testing to assess their stroke risk.

More information

The U.S. National Institute of Neurological Disorders and Stroke outlines stroke risk factors and prevention.


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Danger From Heart Surgery Drug Confirmed


WEDNESDAY, May 14 (HealthDay News) -- A new Canadian study confirms that people given Trasylol, a drug used to reduce bleeding during heart surgery, face a 53 percent increased risk of death.

Trasylol's German maker, Bayer AG, suspended marketing in the United States last November after preliminary results from this trial revealed problems with the medication. On Wednesday, following release of the new findings, the U.S. Food and Drug Administration said the manufacturer had begun removing any remaining stock of the drug from the U.S. market.

"In the trial, we asked whether aprotinin [Trasylol] was more effective at reducing massive bleeding during high-risk heart surgery compared to other drugs," lead investigator Dr. Dean A. Fergusson, from the University of Ottawa Centre for Transfusion Research, said during a teleconference Monday.

"We also asked were serious complications, such as death and organ failure, lower for aprotinin compared to the two other drugs," Fergusson said.

The report was released online Wednesday by the New England Journal of Medicine and will appear in its May 29 issue.

In the Canadian trial, known as BART, Trasylol was compared with two similar drugs Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid).

During the trial, 2,331 high-risk cardiac patients undergoing heart surgery were randomly assigned to one of the three drugs.

"The most important outcome of the trial was a bit of surprise," co-principal investigator Dr. Paul C. Hebert, a critical care physician at Ottawa Hospital, said during Monday's teleconference.

The rate of death from Trasylol was 6 percent versus 3.9 percent and 4 percent for the other two drugs, Hebert said. "This represents a 53 percent of relative risk of dying, which translates into for every 50 patients treated with aprotinin, one patient would die," he said.

Most of the deaths associated with Trasylol were from cardiac complications, Hebert said. Because of the significant increased risk of death, the trial was stopped in October 2007, before the scheduled completion date.

The researchers concluded that while Trasylol may have a small advantage in reducing massive bleeding, the increased risk of death precluded the use of the drug in patients undergoing high-risk heart surgery. "That's the statement at the end of the paper, and we stick by it," Hebert said.

However, despite the drug being pulled off the market in many countries, Bayer continues to sell Trasylol in some areas of the world.

"Trasylol, currently under temporary market suspension worldwide, continues to be available in some countries under special access programs as reviewed and agreed to with the relevant regulatory bodies in those markets," said Bayer spokeswoman Staci Gouveia.

Gouveia noted that Bayer is continuing to keep its options open as to whether it will try to reintroduce the drug.

"Bayer will continue to carefully review this article, the editorial and [when available] the underlying data on which the authors have based their conclusions and continue to discuss both the restricted access programs for Trasylol and the worldwide temporary marketing suspension of the drug with regulatory authorities," Gouveia said.

But one expert thinks the results of this trial end the use of Trasylol during cardiac surgery.

"For all practical purposes, unless there is surprising new data, the BART findings preclude future use of aprotinin in cardiac surgery, even though we don't fully understand why the increased risk of death occurs," said Wayne A. Ray, director of the Division of Pharmacoepidemiology at Vanderbilt University School of Medicine and author of an accompanying journal editorial.

Ray noted that the results of this trial were different from those of other trials, which found no increased risk of death.

"However, this was because the earlier trials were mostly small and not designed to study death," Ray said. "Future studies of drugs to prevent blood loss in cardiac surgery must be designed to look at death and other important clinical consequences, rather than only focusing on blood loss."

Another expert thinks the study starkly shows the dangers of Trasylol.

"This is yet another striking demonstration of the risk of aprotinin," said Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine.

Trasylol had been on the market since 1987 and was widely used.

The big questions remaining are "why it takes so long for the truth to come out? And how many patients were lost because of this misadventure in therapeutics?" Topol said.

Topol thinks there is enough blame to go around. "Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?" he asked.

The U.S. Food and Drug Administration is also very high on the blame list, Topol said. "The FDA has to be considered part of the problem," he said. "Why weren't trials like this part of the early approval process, rather than getting the data many years later?"

More information

For more on heart bypass surgery, visit the U.S. National Library of Medicine.


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